BEUDAMED
    FDA Recall Terminated

    Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic

    Recall: Z-0687-2020 · Initiated November 18, 2019

    Recall

    Recall Number
    Z-0687-2020
    Event Number
    84293
    Firm
    Southwest Technologies Inc
    FEI Number
    1929833
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    November 18, 2019
    Posted
    December 13, 2019
    Terminated
    August 23, 2024
    Address
    1746 E Levee St, Kansas City, MO, 64116-4404

    Description

    Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile. UPC 45713-58000 Bacteriostatic

    Reason

    Elasto-Gel Wound Dressing may be contaminated with mold.

    Action

    Customers were first notified November 18, 2019 via email. The email identified the affected product, provided shipping dates, stated the reason for the recall, instructed that product stop being used, and asked for unused product to be returned. A response form was asked to be completed and returned. Questions can be directed to 1-800-247-9951 or email a [email protected].

    Distribution

    CA, GA, IL, KS, NY, OH, TN, TX, VA

    Quantity

    3260 eaches (5 eaches per retail box)